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510(k) K201232

Limbus Contour by Limbus Ai, Inc. — Product Code LLZ

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
August 13, 2020
Date Received
May 7, 2020
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
System, Image Processing, Radiological
Device Class
Class II
Regulation Number
892.2050
Review Panel
RA
Submission Type

Other clearances by Limbus Ai, Inc.

  • K241837 — Limbus Contour (October 9, 2024)
  • K230575 — Limbus Contour (April 7, 2023)

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